Effects of a Dietary Intervention Based on the Dietary Guidelines for the Brazilian Population on the Reduction of Menopausal Symptoms in Overweight and Obese Women

NCT07822230 | Recruiting

• 1 other identifier: CAAE93638725.5.3001.5345
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The menopausal transition is associated with significant hormonal changes that negatively impact many women's quality of life. Vasomotor symptoms, sleep disturbances, mood changes, and genitourinary symptoms are frequently reported during this period. Concurrently, there is a tendency toward increased body weight and fat redistribution, specifically central fat accumulation, which raises the risk of metabolic diseases. Although hormonal therapy is effective, it is not suitable for all women, necessitating the consideration of non-pharmacological strategies as therapeutic alternatives. Scientific evidence indicates that healthy dietary patterns and weight loss are associated with reduced menopausal symptom severity. The objective of the research is to evaluate the effects of a dietary intervention based on the guidelines of the Dietary Guidelines for the Brazilian Population (GAPB) on the reduction of menopausal symptoms. A randomized clinical trial will be conducted to assess whether improving dietary quality and reducing body weight contribute to alleviating menopausal symptoms. Participants will be assigned to two groups: a control group (CG) and an intervention group (IG). Both groups will receive nutritional guidance based on the GAPB; however, the CG will receive the guidelines in printed format, whereas the IG will receive them through group sessions. The study will include perimenopausal or postmenopausal women who are overweight or obese and experiencing menopausal symptoms. Validated instruments will be administered at the beginning and end of the study to assess dietary patterns, menopausal symptoms, and nutritional status.

Conditions

Menopause; Menopause Hot Flashes; Postmenopause; Climactericum; Perimenopause, Climacteric Syndrome; Menopause Related Conditions; Overweight , Obesity; Menopause-related Hot Flashes; Menopause Symptoms

Keywords

menopause; postmenopause; perimenopause; overweight; obesity; climacteric

Outcome Measures

Primary Outcomes (1)

• Menopausal Symptoms

  Baseline and outcome variables will be collected for both groups (control and intervention) prior to the start and at the end of the five-month follow-up period. Menopausal symptom intensity, measured using the Menopause Rating Scale (MRS) questionnaire, will be the primary outcome indicator. This instrument assesses 11 symptoms on a scale of 0 to 4, where 0 indicates no complaints, 1 mild, 2 moderate, 3 severe, and 4 very severe, with a maximum possible score of 44 points.

  From the enrollment period to the end of the study: 5 months.

Secondary Outcomes (3)

• Dietary pattern

  From the date of enrollment to the end of the intervention: 5 months

• Body mass index

  From the date of enrollment to the end of the intervention: 5 months

• Waist circumference

  From the date of enrollment to the end of the intervention: 5 months

Study Arms (2)

Control group (CG)

OTHER

The control group will receive nutritional guidance on healthy eating based on the Dietary Guidelines for the Brazilian Population, provided exclusively as printed material distributed at the start of the study. The guidance will be standardized, with no individual follow-up or in-person meetings.

Other: Nutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population only in printed material

Intervention group (IG)

ACTIVE COMPARATOR

The intervention group will receive nutritional guidance on healthy eating, based on the Dietary Guidelines for the Brazilian Population, provided via printed materials and five monthly in-person sessions.

Other: Nutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population in printed material and 5 in-person and virtual meetings

Interventions

Nutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population in printed material and 5 in-person and virtual meetings OTHER

The intervention group will participate in five monthly Food and Nutrition Education sessions based on the Dietary Guidelines for the Brazilian Population. The first session will be an individual session on nutritional guidance, while the second will be a virtual group session on the NOVA food classification system. The third session will be a virtual group session on nutrition labeling. The fourth session will be a virtual group session on reducing culinary ingredients (salt, sugar, and fat) in food preparation. The fifth session will be an in-person group cooking workshop focused on preparing healthy and practical recipes.

Intervention group (IG)

Nutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population only in printed material OTHER

The control group will receive nutritional guidance on healthy eating based on the Dietary Guidelines for the Brazilian Population, provided exclusively as printed material distributed at the start of the study. The guidance will be standardized, with no individual follow-up or in-person meetings.

Control group (CG)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Only female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 40 to 65 years
• In the perimenopausal or postmenopausal stage (based on clinical criteria and/or self-report)
• Exhibiting clinical symptoms characteristic of menopause
• Diagnosed as overweight or obese (BMI ≥ 25 kg/m²)
• Internet access via mobile phone or computer
• Agreeing to participate by signing the Informed Consent Form (ICF)

You may not qualify if:

• Pregnancy
• Undergoing hormone replacement therapy
• Taking medications for obesity
• Diagnosed with active neoplasms undergoing chemotherapy or immunosuppressive treatment
• Cognitive impairment

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead
• Irmandade Santa Casa de Misericórdia de Porto Alegre: collaborator

Study Sites (1)

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050170, Brazil

RECRUITING

Related Publications (29)

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MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fernanda M Busnello, PhD

  Federal University of Health Science of Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor , PhD

Model Details: This is a randomized, parallel-group clinical trial with a 1:1 allocation ratio comparing a dietary intervention based on the Dietary Guidelines for the Brazilian Population with the control intervention.

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Locations

BR (1)